Trials / Completed
CompletedNCT01155609
L-lysine in Treating Oral Mucositis in Patients Undergoing Radiation Therapy With or Without Chemotherapy For Head and Neck Cancer
L-lysine in the Treatment of Oral Mucositis in Head and Neck Cancer Patients- A Pilot Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- University of Washington · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This pilot clinical trial studies L-lysine in treating oral mucositis in patients undergoing radiation therapy with or without chemotherapy for head and neck cancer. L-lysine may lessen the severity of oral mucositis, or mouth sores in patients receiving radiation therapy with or without chemotherapy for head and neck cancer
Detailed description
PRIMARY OBJECTIVES: I. To determine the complete response rate, decrease in severity, and time to complete response of oral mucositis related to head and neck cancer irradiation and chemotherapy after using L-lysine supplementation daily. SECONDARY OBJECTIVES: I. To determine the functional impact of use of L-lysine for oral mucositis on daily life as measured by the Functional Life Index-Cancer (FLIC) Questionnaire total score. OUTLINE: Patients receive L-lysine orally (PO) once daily (QD) until completion of radiotherapy and resolution of mucositis in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up weekly until mucositis resolves.
Conditions
- Mucositis
- Oral Complications of Chemotherapy
- Oral Complications of Radiation Therapy
- Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
- Recurrent Basal Cell Carcinoma of the Lip
- Recurrent Lymphoepithelioma of the Nasopharynx
- Recurrent Lymphoepithelioma of the Oropharynx
- Recurrent Mucoepidermoid Carcinoma of the Oral Cavity
- Recurrent Salivary Gland Cancer
- Recurrent Squamous Cell Carcinoma of the Hypopharynx
- Recurrent Squamous Cell Carcinoma of the Larynx
- Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
- Recurrent Squamous Cell Carcinoma of the Nasopharynx
- Recurrent Squamous Cell Carcinoma of the Oropharynx
- Recurrent Verrucous Carcinoma of the Larynx
- Recurrent Verrucous Carcinoma of the Oral Cavity
- Stage I Adenoid Cystic Carcinoma of the Oral Cavity
- Stage I Basal Cell Carcinoma of the Lip
- Stage I Lymphoepithelioma of the Nasopharynx
- Stage I Lymphoepithelioma of the Oropharynx
- Stage I Mucoepidermoid Carcinoma of the Oral Cavity
- Stage I Salivary Gland Cancer
- Stage I Squamous Cell Carcinoma of the Hypopharynx
- Stage I Squamous Cell Carcinoma of the Larynx
- Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage I Squamous Cell Carcinoma of the Nasopharynx
- Stage I Squamous Cell Carcinoma of the Oropharynx
- Stage I Verrucous Carcinoma of the Larynx
- Stage I Verrucous Carcinoma of the Oral Cavity
- Stage II Adenoid Cystic Carcinoma of the Oral Cavity
- Stage II Basal Cell Carcinoma of the Lip
- Stage II Lymphoepithelioma of the Nasopharynx
- Stage II Lymphoepithelioma of the Oropharynx
- Stage II Mucoepidermoid Carcinoma of the Oral Cavity
- Stage II Salivary Gland Cancer
- Stage II Squamous Cell Carcinoma of the Hypopharynx
- Stage II Squamous Cell Carcinoma of the Larynx
- Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage II Squamous Cell Carcinoma of the Nasopharynx
- Stage II Squamous Cell Carcinoma of the Oropharynx
- Stage II Verrucous Carcinoma of the Larynx
- Stage II Verrucous Carcinoma of the Oral Cavity
- Stage III Adenoid Cystic Carcinoma of the Oral Cavity
- Stage III Basal Cell Carcinoma of the Lip
- Stage III Lymphoepithelioma of the Nasopharynx
- Stage III Lymphoepithelioma of the Oropharynx
- Stage III Mucoepidermoid Carcinoma of the Oral Cavity
- Stage III Salivary Gland Cancer
- Stage III Squamous Cell Carcinoma of the Hypopharynx
- Stage III Squamous Cell Carcinoma of the Larynx
- Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage III Squamous Cell Carcinoma of the Nasopharynx
- Stage III Squamous Cell Carcinoma of the Oropharynx
- Stage III Verrucous Carcinoma of the Larynx
- Stage III Verrucous Carcinoma of the Oral Cavity
- Stage IV Adenoid Cystic Carcinoma of the Oral Cavity
- Stage IV Basal Cell Carcinoma of the Lip
- Stage IV Lymphoepithelioma of the Nasopharynx
- Stage IV Lymphoepithelioma of the Oropharynx
- Stage IV Mucoepidermoid Carcinoma of the Oral Cavity
- Stage IV Salivary Gland Cancer
- Stage IV Squamous Cell Carcinoma of the Hypopharynx
- Stage IV Squamous Cell Carcinoma of the Larynx
- Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage IV Squamous Cell Carcinoma of the Nasopharynx
- Stage IV Squamous Cell Carcinoma of the Oropharynx
- Stage IV Verrucous Carcinoma of the Larynx
- Stage IV Verrucous Carcinoma of the Oral Cavity
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | quality-of-life assessment | Ancillary studies |
| PROCEDURE | management of therapy complications | Discontinue supplement; treat symptomatically |
| DIETARY_SUPPLEMENT | L-lysine | Given PO |
Timeline
- Start date
- 2010-09-01
- Primary completion
- 2011-12-01
- Completion
- 2012-10-01
- First posted
- 2010-07-02
- Last updated
- 2013-05-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01155609. Inclusion in this directory is not an endorsement.